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Diss Factsheets
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EC number: 944-892-8 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-10-17 to 2017-10-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of butyl palmitate and butyl oleate and butyl (9Z,12Z)-octadeca-9,12-dienoate and 482-680-2
- EC Number:
- 944-892-8
- Molecular formula:
- not applicable
- IUPAC Name:
- Reaction mass of butyl palmitate and butyl oleate and butyl (9Z,12Z)-octadeca-9,12-dienoate and 482-680-2
- Test material form:
- liquid: viscous
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: Human reconstucted epidermises
- Cell source:
- other: SkinEthic(TM)
- Source strain:
- not specified
- Details on animal used as source of test system:
- Human reconstructed epidermises SkinEthic(TM) RHE model (0.5 cm2), maintained according to the supplier's instructions.
- Justification for test system used:
- This study is carried out according to the OECD guideline 439 dated July 28th, 2015 and the epidermis supplier Standard Operating Protocol.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The certificate of analysis from the batch of epidermises with the viability, assessment of barrier function, the morphology and the determination of the absence of biological contamination is attached at the end of the report.
Irritation test was started at the epidermises receipt - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 16 µL +/- 0.5 µL of the test item or reference item were deposited with a positive displacement micropipette.
- Duration of treatment / exposure:
- The epidermises were incubated in 0.3 mL of maintenance medium (24 wells plate) at room temperature for 42 minutes +/- 1 minute.
- Duration of post-treatment incubation (if applicable):
- 42 hours post-treatment incubation
- Number of replicates:
- Test item as well as the reference items were tested on three epidermises.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean viability
- Value:
- 95.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Results table - ID-17/08642
Assessment of viability | Conclusion | |||||||||
(Abs. - blanc) | Mean Abs./Ep | Viability/Ep % | Standard deviation | Viability means % | ||||||
Negative control | Ep. 1 | 1.357 | 1.430 | 1.421 | 1.402 | 106.0% | 5.5% | 100.0% | Non irritant | |
Ep. 2 | 1.271 | 1.334 | 1.310 | 1.305 | 98.7% | |||||
Ep. 3 | 1.233 | 1.288 | 1.261 | 1.260 | 95.3% | |||||
Positive control | Ep. 1 | 0.049 | 0.051 | 0.052 | 0.050 | 3.8% | 0.5% | 3.4% | Irritant | |
Ep. 2 | 0.044 | 0.047 | 0.047 | 0.046 | 3.5% | |||||
Ep. 3 | 0.037 | 0.039 | 0.039 | 0.038 | 2.9% | |||||
ID-17/08642 | Ep. 1 | 1.401 | 1.411 | 1.393 | 1.401 | 106.0% | 5.1% | 100.9% | Non irritant | |
Ep. 2 | 1.326 | 1.356 | 1.332 | 1.338 | 101.2% | |||||
Ep. 3 | 1.278 | 1.245 | 1.274 | 1.265 | 95.7% | |||||
T living NS | - | - | - | - | - | - | Corrected viability 95.1% |
|||
MTT NS | 0.077 | 0.081 | 0.073 | 0.077 | 5.8% | 0.4% | ||||
T death NS | - | - | - | - | - | - |
Applicant's summary and conclusion
- Interpretation of results:
- other: not be classified
- Conclusions:
- Under the retained experimental conditions and according to the CLP regulation, the test item BUTYL AVOCADATE DISTILLE - REF : 8500013 - BATCH : 17-04-15001 code ID-17/08642 tested pure must not be classified. No symbol, risk phrase, no signal word or hazard statement is required.
- Executive summary:
Title: In vitro skin irritation study of a test item on human reconstructed epidermis (SkinEthic model) according to the OECD guideline 439
Objective: The aim of the study id the evaluation of a test item capability to induce skin irritation effects by a cytotoxicity test on in vitro human reconstructed epidermises (SkinEthic(TM) RHE model).
After the test item application, pure, on epidermis for 42 minutes and 42 hours post-treatment incubation, cellular viability is evaluated by the measurement of the succinate deshydrogenase mitochondrial activity of the alive cells. This enzyme is involved in the transformation of MTT (3(4,5 -dimethylthiazol-2 -yl)-2,5 -diphenyltetrazolium bromide) into blue formazan cristal. A spectrophotometric measurement is performed after the crystal dissolution. The measured absorbances are proportional to the number of living cells.
This study is carried out according to the OECD guideline 439 dated July 28th, 2015 and the epidermis supplier Standard Operating Protocol.
Test item: BUTYL AVOCADATE DISTILLE - REF : 8500013 - BATCH : 17 -04 -15001
Test system: Human reconstructed epidermis SkinEthic(TM) RHE model (0.5 cm2) maintained according to the supplier's instructions.
Conclusion: Under the retained experimental conditions and according to the CLP regulation, the test item BUTYL AVOCADATE DISTILLE - REF : 8500013 - BATCH : 17-04-15001 code ID-17/08642 tested pure must not be classified. No symbol, risk phrase, no signal word or hazard statement is required.
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